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ISO 12891-1:2015

Current
Current

The latest, up-to-date edition.

Retrieval and analysis of surgical implants Part 1: Retrieval and handling
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

06-19-2015

Publisher

International Organization for Standardization

ISO 12891-1:2015 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. It also provides guidance on infection control.

NOTE National or other regulations, which can be more stringent, can apply.

ISO 12891-1:2015 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.

DevelopmentNote
Supersedes ISO/DIS 12891-1. (06/2015)
DocumentType
Standard
Pages
24
PublisherName
International Organization for Standardization
Status
Current
Supersedes

Standards Relationship
NEN ISO 12891-1 : 2015 Identical
BS ISO 12891-1:2015 Identical
GOST R ISO 12891-1 : 2012 Identical

ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
BS ISO 12891-2:2014 Retrieval and analysis of surgical implants Analysis of retrieved surgical implants
15/30290736 DC : 0 BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
ASTM F 561 : 2013 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
BS EN ISO 14630:2012 Non-active surgical implants. General requirements
I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
BS EN ISO 10993-4:2017 Biological evaluation of medical devices Selection of tests for interactions with blood
17/30319534 DC : 0 BS ISO 13019 - TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULPHATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS
04/300654 DC : DRAFT JAN 2004 BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
CSA ISO TR 14969 : 2005 : R2010 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
ISO 12891-4:2000 Retrieval and analysis of surgical implants Part 4: Analysis of retrieved ceramic surgical implants
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
ISO 12891-3:2000 Retrieval and analysis of surgical implants Part 3: Analysis of retrieved polymeric surgical implants
UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
BS PD ISO/TR 14969 : 2004 AMD 15958 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
03/314215 DC : DRAFT OCT 2003 ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
13/30242622 DC : 0 BS ISO 12891-2 - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 2: ANALYSIS OF RETRIEVED SURGICAL IMPLANTS
CSA ISO TR 14969 : 2005 : R2015 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
ISO 13019:2018 Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
ISO 12891-2:2014 Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants
DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
UNE-EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012)
EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
ASTM F 3037 : 2015 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)
UNE-EN ISO 10993-4:2018 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
I.S. EN ISO 10993-4:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017)
ISO 14630:2012 Non-active surgical implants General requirements

ASTM F 561 : 2013 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
NSF 49 : 2016 BIOSAFETY CABINETRY: DESIGN, CONSTRUCTION, PERFORMANCE, AND FIELD CERTIFICATION
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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